Events

Rappel de Venture RX Catheter,Venture OTW Catheter,Venture CS Catheter

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Vascular Solutions, Inc..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    77202
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-2224-2017
  • Date de mise en oeuvre de l'événement
    2017-04-25
  • Date de publication de l'événement
    2017-05-22
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=155426
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, percutaneous - Product Code DQY
  • Cause
    Vascular solutions, inc. (vsi) is voluntarily removing all lots of venture catheters due to a potential problem. venture rx (model 5820), venture otw (model 5821), and venture cs (model 5822) catheters. after an internal investigation, vsi determined that material used in catheter construction may detach from within the lumen of the distal tip during use.
  • Action
    The firm, Vascular Solutions, sent an "URGENT: Medical Device Recall" letter dated April 25, 2017, to all affected consignees. The letter described the problem and the product involved in the recall and actions to be taken. Consignees were instructed to identify location of all unused product in your possession; immediately cease further use or distribution, remove any unused product , place it in a secure area, and complete and return the VSI Account Inventory Form by email to: customerservice@vascom or fax to (763)656-4251. VSI Customer Service Department will contact consignees for return authorization of the product. If you have any specific questions or concerns regarding this matter, please contact your local sales representative or call 763-656-4300.

Device

Venture RX Catheter,Venture OTW Catheter,Venture CS Catheter
  • Modèle / numéro de série
    581713 582455 582588 583022 583409 583410 584469 584470 599777 584471 585180 585458 585459 585787 586408 586972 587035 587036 587408 587775 588097 588098 588099 588100 588794 589268 589754 589885 589886 590172 590404 590562 590776 591196 591197 591198 592080 592081 592526 592924 593080 593519 593520 593720 594204 594421 595195 595196 595418 595419 596020 597293 597294 597771 597905 597967 598903 599045 599466 599650 599903 601196 601745 601746 602260 603987 603988 603990 603991 604049 604500 604862 605617
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide): including states of: AK, AL, AR, AZ, CA, CO, CT, DC,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, ME, MI, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY; and countries of: AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CZECH REPUBLIC, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, LEBANON, NETHERLANDS, NORWAY, POLAND, RUSSIA, SAUDI ARABIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY,and UK.
  • Description du dispositif
    Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. || The Venture catheter is indicated for directing, steering, controlling, and supporting a guidewire to access discrete regions of the coronary and peripheral vasculature. The OTW versions (Models 5821 and 5822) may also be used for manual delivery of saline solution or diagnostic contrast agents
  • Manufacturer
    Vascular Solutions, Inc.

Manufacturer

Vascular Solutions, Inc.
  • Adresse du fabricant
    Vascular Solutions, Inc., 6464 Sycamore Ct N, Maple Grove MN 55369-6032
  • Société-mère du fabricant (2017)
    Teleflex Incorporated
  • Source
    USFDA